Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reusable and Disposable SpO2 Sensors

K-Number: K201360 · 2020-08-19

ApplicantXinkang Medical Instrument Co. , Ltd.
Decision Date2020-08-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reusable and Disposable SpO2 Sensors is a medical device manufactured by Xinkang Medical Instrument Co. , Ltd.. It received FDA 510(k) clearance on 2020-08-19 under approval number K201360. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reusable and Disposable SpO2 Sensors?

Reusable and Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Xinkang Medical Instrument Co. , Ltd.. The 510(k) number is K201360.

When was Reusable and Disposable SpO2 Sensors approved by the FDA?

Reusable and Disposable SpO2 Sensors received FDA 510(k) clearance on 2020-08-19, under approval number K201360.

What company makes Reusable and Disposable SpO2 Sensors?

Reusable and Disposable SpO2 Sensors is manufactured by Xinkang Medical Instrument Co. , Ltd..

What is the FDA product code for Reusable and Disposable SpO2 Sensors?

The FDA product code for Reusable and Disposable SpO2 Sensors is DQA.

Related Clinical Trials

NCT07539701 An Initial Experience With the Disposable Celsio Cryocatheter System for Diagnostic and Interventional Bronchoscopy NOT_YET_RECRUITING NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances RECRUITING NCT07349797 MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure NOT_YET_RECRUITING NCT07335614 Evaluation of Protein Loading on Measurement of Renal Reserve NOT_YET_RECRUITING

Other Devices by Xinkang Medical Instrument Co. , Ltd.

K201359ECG Cables and Leadwires

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑